Protecta-Gel®
Basic Information
- Brand Name
- Protecta-Gel®
- Primary DI
- 10850009091038
- Version / Model
- JRJ 41501
- Catalog Number
- JRJ 41501
- Company Name
- J.R.J. MEDICAL INNOVATIONS, LLC
- Labeler DUNS
- 015629325
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-01-10
- Public Version
- 2
- Public Version Date
- 2022-11-09
- Public Version Status
- Update
- Public Device Record Key
- aee92b02-c845-4c0c-a801-f26c0083c506
Device Description
Protecta-Gel® Facial Skin Barrier, Regular. Hypoallergenic and made from medical grade mineral oil-based gel. Super soft barrier between the patient's skin and their full face mask or nasal mask. Unique patented "pressure absorbing ribs" to help increase comfort and decrease soreness, marks and wounds to the nasal bridge, upper and lower cheek bone areas. Unlike other “gels or dressings currently on the market, the Protecta-Gel® is patented with a unique “Rib” like design solely responsible for added protection. This unique design replicates shock absorbers which create comfort for Non Invasive ventilation (NIV), CPAP full face mask users. The Protecta-Gel® allows the caregiver or user to “cut” or “trim” the product to size to ensure a more accurate fit. Tapered ends will help to prevent leaks and improve comfort. No adhesives necessary. Easy to clean with mild soap and water. Air dry. Replace after 30 days of use.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMP | Protector, Skin Pressure | General Hospital | 880.6450 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10035 | Skin surface device adhesive | A substance (e.g., gel, aerosol) intended to adhere a medical device (e.g., dressing, ostomy device, aesthetic restoration prosthesis) to the skin surface; it is not intended for invasive/surgical use but may be intended for other non-patient contact uses. It may be used in the home or healthcare facility. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30850009091032 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 10850009091038 | GS1 |
Customer Contacts
- Phone
- 9999999999
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 4.75 | Inch | |
| Width | 4 | Inch | |
| Height | 3.5 | Millimeter |